Lancet device

ABSTRACT

A lancet device including a housing with an at least partially open interior, a cocking seat coupled with the housing and structured to define an open interior therewith, a lancet with a piercing tip moveably disposed within the open interior, and a biasing assembly engaging the lancet. The cocking seat is structured to engage the lancet and retain the lancet against a force of the biasing assembly so as to maintain a potential energy of the biasing assembly. A release element is provided to at least partially disengage the lancet from the cocking seat such that the potential energy of the biasing assembly moves the lancet relative to the cocking seat and drives the piercing tip of the lancet at least temporarily into a piercing orientation.

CLAIM OF PRIORITY

[0001] The present application is a continuation-in-part application ofpreviously filed, now pending application having Ser. No. 10/134,995,filed on Apr. 29, 2002.

BACKGROUND OF THE INVENTION

[0002] 1. Field of the Invention

[0003] The present invention relates to a lancet device preferablyconfigured to provide a single use, and in all embodiments configured tosubstantially shield and protect a piercing tip thereof before and afteruse, while providing for accurate and effective piercing engagement of apatient's skin when appropriate. Furthermore, the present lancet devicedoes not require complex and/or difficult to manipulate cocking and isstructured such that the device is rendered in-operative after a singleuse.

[0004] 2. Description of the Related Art

[0005] Lancets are commonly utilized instruments which are employed bothin hospitals and other medical facilities, as well as by privateindividuals, such as diabetics, in order to prick or pierce a patient'sskin, typically on a finger of a patient, thereby leading to thegeneration of a blood sample which can be collected for testing. Becauseof the wide spread use of such lancets, there are a variety of lancetdevices which are available for utilization by patients and/orpractitioners in a variety of different circumstances.

[0006] For example, a typical lancet may merely include a housing with asharp piercing tip that is pushed into the patient's skin. Morecommonly, however, lancet devices, which house a piercing tip and/or alancet, have been developed which effectively encase and fire the lancetinto the patient's skin, thereby eliminating the need for the persontaking the sample to actually push the lancet tip into the skin.

[0007] Within the various types of specialized lancet devices, onevariety are typically configured for multiple and/or repeated uses,while another category is particularly configured for single use, afterwhich the entire device is disposed of. Looking in particular to thesingle use, disposable lancet devices, such devices typically include ahousing which contains and directs or drives a piercing tip into thepatient's skin, and which is disposed of along with the used lancet.Naturally, so as to make such disposable devices cost effective forfrequent use, such devices tend to be rather simplistic in natureproviding only a sufficient mechanism for firing, and not overlycomplicating the design so as to minimize that cost.

[0008] While existing single use devices are generally effective forachieving the piercing of the skin required for effective operation,such single use, disposable devices typically do not incorporate a largenumber of safety features to ensure the safe use and disposal of thedevice. For example, one primary area of safety which must be addressedwith all lancet devices pertains to the purposeful and/or inadvertentreuse of a contaminated lancet. Unfortunately, most currently availablesingle use lancet devices are configured such that after a use thereofhas been achieved, it is possible for a patient to re-cock the device,thereby allowing for a subsequent, inappropriate use.

[0009] As a result, it would be highly beneficial to provide a singleuse lancet device which is substantially compact and disposable, can bemanufactured in a substantially cost effective manner, and whichnevertheless is substantially safe to utilize, affirmatively preventingre-use, once contaminated.

[0010] A further drawback associated with conventionally employed singleuse lancet devices is that they can often be difficult and/orcomplicated for elderly and/or impaired individuals to manipulate inorder to achieve effective use. In particular, such existing devicesoften require a user to perform a number of different actions, includingone to cock and thereby prepare the device for use, and another toactually fire the device. As can be appreciated, those procedures, evenin the simplest form, can sometimes be complex and/or difficult toeffectively achieve on a small compact device by certain individuals,and especially those individuals performing self testing who necessarilyonly have one hand to use to manipulate the device. Indeed, to avoidthese complexities, some manufactures have turned to the use ofpre-cocked and ready to use devices, however, this can often result inmisfires and/or pre-fires of the lancet such that a certain ofpercentage of the lancet devices are not usable.

[0011] As a result, it would also be beneficial to provide a lancetdevice, which whether single use and/or multiple use, could be verysimplistic and effective to employee, not requiring a series of oftencomplex activities to be perform in order to prepare the lancet for useand in order to actually utilize the lancet. Still, however, such adevice should not comprise safety in the prevention of inadvertent useand/or re-use in exchange for the simplistic use, but rather shouldeffectively coordinate all such beneficial characteristics. It wouldalso be beneficial such a device could be effectively and costeffectively manufacture so as to make it available and affordable to alarge variety of users, including home users.

SUMMARY OF THE INVENTION

[0012] The present invention relates to a lancet device, and preferablya single use lancet device, utilized so as to effectively pierce apatient's skin and result in bleeding for subsequent sample collection.The lancet device of the present invention preferably includes a housinghaving an at least partially open interior. Furthermore, a lancet ismovably disposed relative to the housing and includes a piercing tipwhich ultimately will penetrate the patient's skin. Similarly, a biasingassembly is interposed between the lancet and the housing. The biasingassembly engages the lancet and functions to urge the lancet into itspiercing orientation, when appropriate.

[0013] The lancet device of the present invention also includes acocking seat. The cocking seat is structured to engage the lancet andretain the lancet against the force of the biasing assembly so as toestablish a potential energy of the biasing assembly. In the preferredembodiment, the user's finger and/or another body part which is to bepierced, engages the cocking seat and thereby pushes the cocking seatand the lancet until it ultimately engages a release assembly thatextends into the housing. In alternate embodiments, the cocking seat isintegrally or separately disposed relative to the housing to retain thelancet against the force of a biasing element until released by anacuatable release assembly. The release assembly is structured todisengage the lancet from the cocking seat such that the potentialenergy of the biasing assembly drives the piercing tip of the lancet atleast temporarily into its piercing orientation. As a result, in oneillustrated embodiment, as the cocking seat moves the lancet,simultaneously cocking it and moving it into its engaging relation withthe release element for effective actuation and firing thereof to piercethe skin of the patient, while in another embodiment, the lancet deviceis “pre-cocked”.

[0014] These and other features and advantages of the present inventionwill become more clear when the drawings as well as the detaileddescription are taken into consideration.

BRIEF DESCRIPTION OF THE DRAWINGS

[0015] For a fuller understanding of the nature of the presentinvention, reference should be had to the following detailed descriptiontaken in connection with the accompanying drawings in which:

[0016]FIG. 1 is a side cross-sectional view of a preferred embodiment ofthe lancet device of the present invention in an un-used orientation;

[0017]FIG. 2 is a side cross-section view of the embodiment of FIG. 1 ina substantially cocked and immanent to release orientation;

[0018]FIG. 3 is a side cross-sectional view of a further embodiment ofthe lancet device of the present invention;

[0019]FIG. 4 is an exploded view of the lancet device and cocking seatof a preferred embodiment of the present invention;

[0020]FIG. 5 is a side cross-section view of still another embodiment ofthe lancet device of the present invention illustrating a re-usableconfiguration thereof; and

[0021]FIG. 6 is a side cross-section view of another embodiment of thelancet device of the present invention illustrating a fixed cockingseat.

[0022] Like reference numerals refer to like parts throughout theseveral views of the drawings.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

[0023] Shown throughout the Figures, the present invention is directedtowards a lancet device, generally indicated as 10. In one embodiment ofthe present invention, as illustrated in FIGS. 1 through 3 and 6 thelancet device 10 is preferably a single use device such that after it isutilized for the first and only time it is configured so as to preventsubsequent use. Ultimately, however, as illustrated in FIG. 5, are-usable configuration may be provided.

[0024] Looking specifically to the Figures, the lancet device of thepresent preferably includes a housing 20. The housing 20 includes an atleast partially open interior 22 and can be made of any varietymaterials, but preferably will be formed of a molded plastic typematerial for ease of manufacture and minimization of cost. Also in thepreferred embodiment, the housing 20 preferably includes an open end 26,which may represent a general front of the lancet device 10, and mayinclude any variety of axial configurations, including a square,triangle, oval, circle, etc., although a generally elongated,longitudinal configuration as illustrated in the Figures is preferred inconjunction therewith.

[0025] The lancet device 10 further includes a lancet 40 movablydisposed at least partially within the housing 20 and including apiercing tip 42. In the single use embodiment of FIGS. 1 through 3 and 6the lancet 40 is a single integral unit as shown. Alternatively, asillustrated in the embodiment of FIG. 5, what is referred to as a lancetin the claims may include a lancet body 40′ from which the piercing tip42 extends, as well as a lancet receiving assembly 41, into which thelancet body 40′ is disposed for movable retention. In such anembodiment, each time the lancet device 10 is to be re-used, a newlancet body 40′ with piercing tip 42 is disposed within the lancetreceiving assembly 41. In either embodiment, however, the lancet ismovably disposed within the housing 20.

[0026] Preferably the lancet engages a biasing assembly also preferablydisposed within the housing 20. In the illustrated preferredembodiments, the biasing assembly includes a biasing element 50 such asa metal or plastic spring. Preferably, the biasing element 50 isinterposed between the lancet 40 and a rear end 55, 55′ of the housing20. The rear end 55, 55′ may be unitary or separate from the housing 20.Moreover, positioned so as to engage the lancet 40 and retain it underthe tension of the biasing assembly 50 is a cocking seat 30. Inparticular, the cocking seat 30 is structured to engage the lancet 40and retain the lancet 40 against a force of the biasing assembly 50 soas to maintain a potential energy of the biasing assembly 50. In someillustrated embodiments, and as best seen in FIG. 2, the cocking seat 30urges the lancet 40 towards the rear end of the lancet housing 20,thereby resulting in a compression of the biasing assembly 50 and anincrease in the potential energy thereof. Further, so as to maintaineffectively appropriate alignment of the lancet and the cocking seat 30as they are moving relative to the housing 20, in the preferredembodiment, a guide track assembly 24, 32 may be provided between thecocking seat 30 and the housing 20.

[0027] In the preferred, illustrated embodiments, an engagement assembly34, 45 is provided and preferably interposed between the cocking seat 30and the lancet 40 so as to maintain moving engagement between the lancet40 and the cocking seat 30 until they are disengaged, as will bedescribed. In the illustrated embodiments, the engagement assemblyincludes an engagement element 45 that extends from lancet 40 intoeffectively retained, engaging relation with a retention lip 34 on thecocking seat 30. As a result, as the cocking seat 30 moves inwardtowards the rear end 55 of the housing 20, the effective engagementbetween the engagement element 45 and the retention lip 34 results inmovement of the lancet 40 in unison with the cocking seat 30. In thisregard, it is understood that a variety of different engagementassemblies, including one in which the engagement element extends fromthe cocking seat into engagement with a corresponding retention lip onthe lancet, may also effectively be provided, the engagement assemblybeing configured so as to provide for effective substantially, althoughnot necessarily completely, unitary movement between the lancet 40 andthe cocking seat 30 until effective release thereby, as will bedescribed. Further, in yet another embodiment, as seen in FIG. 6, thecocking seat may be pre-introduced into housing, or be integrally formedwith or secured to the housing 20 such that the lancet 40 is effectivelymaintained under a tension of the biasing assembly until released by amoveable release assembly.

[0028] In particular, the present lancet device 10 further includes arelease element 56. In the illustrated embodiments, the engagementelement 45 of the engagement assembly preferably has a generallyflexible and/or resilient characteristic relative to the lancet 40,and/or as will be described, includes a single use pivot 46. As aresult, when the cocking seat 30 and therefore the lancet 40 are urgedsufficiently into an interior 22 of housing 20, the release element 56which also at least partially extends into an interior of the housing 20when firing is desired, serves to engage the engagement element 45, andultimately causes upward movement thereof for disengagement between theengagement element 45 and a retention lip 34. Moreover, thisdisengagement is achieved after a substantial amount of potential energyhas been achieved in the biasing assembly 50. As a result, disengagementbetween the lancet 40 and the cocking seat 30 results in the lancet 40moving relative to the cocking seat 30 under a force achieved by thepotential energy stored in the biasing assembly 50. The guide track 32may also serve to guide generally linear movement of the lancet 40relative to the cocking seat 30, as the lancet 40 moves to the openinterior 31 of the cocking seat 30 and ultimately protrudes through anopening 37 in an exterior end 36 of the cocking seat 30.

[0029] Looking further to the single use pivot 46, this may be definedby a reduce thickness region in the segment that ultimately defines theengagement element. The pivot 46 may be seen to define a breakablehinge, and is configured such that when the release element 56 engagesthe engagement element 45, the engagement element 45 pivots on saidpivot point and cannot generally return to its pre-pivoted orientation.As a result, even if re-positioning of the engagement element relativeto the cocking seat was attempted, the necessary engagement could not beachieved as the reduced thickness portion snaps and or deforms toprevent such re-positioning. A single use of the device is thereforfurther ensured.

[0030] As previously indicated, the cocking seat 30, and preferably theexterior end 36 of the cocking seat 30 may be configured to engage apatient, at least in a general vicinity of a portion to be pierced.Furthermore, in the preferred, illustrated embodiment, the opening 37 atthe end 36 of the cocking seat 30 is preferably aligned with a specificlocation to be pierced, such as on a tip of the finger. That portion ofthe body, such as the finger, is thereby utilized as an abutment on oneof the lancet device 10, while a corresponding support element, such asanother finger or a thumb of the patient, or a hand of a medicalpractitioner or other user, or a solid surface, engages the housing 20of the lancet device 10. In this regard, as either or both the bodysection and the support element are moved towards one another such thata spacing therebetween is reduced, the moveable cocking seat 30 movesfurther into the housing 20 until ultimately the engagement element 45engages and is released by the released element 56. Once this release isachieved, the lancet 40 moves relative to the cocking seat 30 passing,therethrough such that its piercing tip 42 protrudes from the open end37 of the cocking seat 30 and piercingly engages the patient's skin.Therefore, in the embodiments of FIGS. 1 and 2 the cocking movementdirectly results in firing of the lancet 40, requiring only a single,fluid movement to effectively utilize the present lancet device 10.Looking in further detailed to the previous description, it isunderstood that the effective firing can be achieved either by movingthe portion of the patient, such as their finger inward against a fixedsupport element, by moving a support element towards a fixed portion ofthe body to be pierced and/or by compressing both towards one another.

[0031] Turning to the embodiment of FIGS. 3 and 6, it is alsounderstood, that for further safety reasons, if desired, the releaseelement 56 may not necessarily be positioned at all times in anappropriate location to effectively release the lancet 40 from itsengagement with the cocking seat 30. For example, in the embodiment ofFIG. 3 a stopper 25 is position such that movement of the cocking seat30 and therefore the lancet 40 towards the rear end 55′ will not resultin a sufficient travel distance such that the engagement element 45 isreleased by the release element 56. Similarly, in the embodiment of FIG.6 wherein the cocking seat forms part of the housing and the lancet isre pre-cocked, but does not automatically fire. Rather, in theseillustrated embodiments actuation of the rear end 55′ inwardly isrequired so as to effectively move the release element 56 into aposition where it may engage the engagement element 45 and provide forappropriate release of the lancet 40 from the cocking seat 30. Also inthe embodiment of FIG. 3 a spring or a stopper may be provided so as toalso restrict movement of the actuation element 55′, as it is ultimatelypreferred that actuation thereof be utilized only so as to effectivelyposition the release element 56 in a position and orientation such thatthe previous or subsequent movement of the cocking seat 30 and/or thehousing 20 in the manner previously described for cocking and firingresults in the releasing engagement between the release element 56 andthe engagement element 45. Also on such embodiments is recognized that avariety of different actuation assemblies 55′ may be effectivelyprovided so as to position the release element 56 in its appropriateposition to release the lancet. For example, a side, spring loadedbutton and/or resilient button may be provided such that the releaseelement 56 is retained at least partially out of the housing and/or outof engaging relation with the engagement element 45 until it is actuatedand moved at least partially into the interior of the housing 20.Furthermore, as evidenced by the embodiment of FIG. 6, additionalstructure may be provided so as to cock the lancet device, or it may besold pre-cocked with the cocking seat 30 may be pre-positioned in anappropriate position to allow actuation of the release element 56 toeffectively disengage the engagement element 45 from the cocking seat30. As mentioned, in such an embodiment, the cocking seat 30 can beretained in position relative to the housing or can merely be integrallyformed with and/or secured to the housing 20, thus eliminating the needto push in the cocking seat 30 and allowing for mere actuation of therelease element 56 to result in disengagement of a properly positionedengagement element.

[0032] Looking again to FIG. 1, further features that may be providedwith the present invention may be the inclusion of a cover element 43which is structured to protect and shield the piercing tip 42 of thelancet 40 prior to use. The cover element 43 preferably extends out fromthe open interior 31 of the cocking seat 30, out through the opening 37so as to be effectively grasped by a user for removal thereof whenpreparing the lancet device 10 for use. Alternately, and exterior coverthat covers the cocking seat and/or surrounds the piercing tip may alsobe provided. It is also noted, that the cocking seat 30 is configuredsuch that even when the cover element 43 is removed, the piercing end 42is protected and/or shielded within the interior 31 thereof unless anduntil use. Indeed, it is only when the driving force of the biasingassembly 50 urges the lancet's movement relative to the cocking seat 30that the piercing tip 42 temporarily passes through the opening 37.Still, as a final safety measure, although a single biasing assembly 50may be sufficient so as to both drive the lancet 40 into its piercingorientation and so as to generally retracted back into its protectiveshielding within the cocking seat 30, in some embodiments a secondarybiasing assembly 52 may also be positioned and interposed between thelancet 40 and the cocking seat 30, the secondary biasing assembly 52being structured and disposed so as to not hinder movement of thepiercing tip 42 into its piercing orientation, but so as to effectivelyretract the lancet 40 back into its protective containment within thecocking seat 30. Moreover, that retraction should not be sufficient soas to return the lancet 40 into its engagement relation with the cockingseat 30 for unitary movement therebetween.

[0033] Since many modifications, variations and changes in detail can bemade to the described preferred embodiment of the invention, it isintended that all matters in the foregoing description and shown in theaccompanying drawings be interpreted as illustrative and not in alimiting sense. Thus, the scope of the invention should be determined bythe appended claims and their legal equivalents.

[0034] Now that the invention has been described,

What is claimed is:
 1. A lancet device comprising: a) a housing, saidhousing including an at least partially open interior; b) a cocking seatdefined in said housing; c) a lancet moveably disposed at leastpartially within said open interior and including a piercing tip; d) abiasing assembly engaging said lancet; e) said lancet including anengagement element; f) said cocking seat structured to engage saidlancet at said engagement element and retain said lancet against a forceof said biasing assembly; g) a release element structured to at leastpartially disengage said engagement element from said cocking seat suchthat said potential energy of said biasing assembly moves said lancetrelative to said cocking seat and drives said piercing tip of saidlancet at least temporarily into a piercing orientation; and h) saidengagement element including a single use pivot structured to rendersaid engagement element inoperative to retain said lancet on saidcocking seat after said release element disengages said engagementelement from said cocking seat.
 2. A lancet device as recited in claim 1wherein said cocking seat is stationary relative to said housing.
 3. Alancet device as recited in claim 1 wherein said cocking seat isstructured to move said lancet into releasing engagement with saidrelease element.
 4. A lancet device as recited in claim 1 wherein saidrelease element is structured to be exteriorily actuated so as todisengage said engagement element from said cocking seat.
 5. A lancetdevice as recited in claim 1 wherein said single use pivot is structuredto be deformed upon said release element disengaging said lancet fromsaid cocking seat so as to prevent repositioning of said lancet inengaged, pre-fired relation with said cocking seat.
 6. A lancet deviceas recited in claim 1 wherein said single use pivot is defined by abreakable hinge structured to break upon said engagement element beingdisengaged from said cocking seat by said release element, therebypreventing re-use thereof.
 7. A lancet device as recited in claim 6wherein said breakable hinge is defined by a reduced thickness sectionof said engagement element.
 8. A lancet device as recited in claim 1wherein said cocking seat comprises a ledge defined in said housing.